Multi-centre prospective randomised trial of early decompressive craniectomy in patients with severe traumatic brain injury

Completed

Conditions: Severe traumatic brain injury
Injury, Occupational Diseases, Poisoning

Registration Number: ISRCTN61037228

Lead Sponsor: ational Trauma Research Institute, The Alfred Hospital (Australia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 165

Inclusion Criteria

1. Age 15-60 years
2. First 72 hours from time of injury
3. Severe diffuse Traumatic Brain Injury defined as:
3.1. Glasgow Coma Score (GCS) <9 and computed tomography (CT) scan with any evidence of brain swelling. CT brain scan DII + some evidence of swelling or DIII or DIV
OR
3.2. GCS >8 before intubation and DIII or DIV. CT brain scan basal cistern compression ± midline shift
4. Intracanial pressure (ICP) monitor in situ
5. 'Refractory ICP' despite best conventional management. Refractory ICP in this study will be defined as the spontaneous persistent increase in ICP despite optimal conventional ICU therapies (including intermittent external ventricular drain [EVD] venting) of >20 mm Hg for more than 15 mins (continuously or cumulative over one hour).

Exclusion Criteria

1. Intracranial mass lesion (>3 cm diameter) and/or previous craniectomy
2. Extradural hematoma / subdural hematoma (EDH/SDH) requiring evacuation
3. EDH/SDH >0.5 cm thickness
4. Spinal cord injury
5. Penetrating brain injury
6. Arrest at scene
7. Unreactive pupils >4 mm and GCS = 3
8. Neurosurgery contraindicated
9. No chance of survival after consideration of CT and clinical findings, following Neurosurgical consultant assessment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Score (GOSE) measured 6 months after the injury. Proportion (%) of Favourable Outcomes (GOSE 5-8) is the primary outcome measure.

Secondary Outcome Measures

Name	Time	Method
1. Mean and maximum hourly ICP<br>2. Favourable outcomes (GOSE 5-8) at 12 months post injury<br>3. Mean GOSE at 6 and 12 months using ordinal logistic regression<br>4. Mortality - hospital, 6 months, 12 months<br>5. Days in intensive care unit (ICU) and hospital